The following data is part of a premarket notification filed by Laprol Scientific, Inc. with the FDA for Uritest 9, Inlab Reagent Strips Urinaly.
| Device ID | K822709 |
| 510k Number | K822709 |
| Device Name: | URITEST 9, INLAB REAGENT STRIPS URINALY |
| Classification | Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) |
| Applicant | LAPROL SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JMA |
| CFR Regulation Number | 862.1095 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-07 |
| Decision Date | 1983-01-28 |